British drug giant GlaxoSmithKline Plc (GSK: Quote,GSK.L) and US biopharma firm Theravance Inc. (THRX: Quote) Monday said that four pivotal phase III studies of their investigational combination drug showed statistically significant improvements in patients with chronic obstructive pulmonary disease, or COPD.
Once-daily LAMA/LABA is a combination of two investigational bronchodilator molecules, which GlaxoSmithKline is developing with Theravance. Subject to successful completion of the ongoing studies, the companies plan to commence global regulatory filings from the end of this year.
GlaxoSmithKline said the studies involved over 4,000 patients with COPD, which had two 24-week efficacy studies that compared the combination LAMA/LABA, its components and placebo. The two 24-week active comparator studies compared the combination with the LAMA, long-acting muscarinic antagonist, tiotropium - a widely prescribed maintenance bronchodilator for COPD.
The first 24-week study involved 1,493 patients and the second 24-week study randomised 1,536 patients. Both showed statistically significant improvements.
In active comparator efficacy studies, the first 24-week study randomised 846 patients and the second 24-week study randomised 872 patients. These studies also resulted in a statistically significant improvement in patients with COPD.
COPD makes breathing difficult and is mainly caused by smoking all though it occurs in non-smokers too. According to reports, more than 12 million American adults suffer from COPD, and another 12 million Americans likely have this lung disease without knowing it.
GSK.L is currently trading at 1,449 pence, up 2 pence or 0.14 percent, on a volume of 1.91 million shares o the LSE. In US, GSK closed Friday's regular trading at $45.57 om the NYSE.
THRX ended on Friday at $22.22 on the Nasdaq.
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by RTT Staff Writer
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